Choose a reviewing HREC and review all relevant requirements and submission deadlines for their meetings.
In the submission package, it is important that it is clear it is a teletrial study and that the Satellite Sites are supervised by the Primary Site. This needs to be outlined in the approval letter.
The Primary Site must ensure all documentation pertaining to the submission processes is filed in the Site Master File.
Changes to the trial set up must be reported to HREC and an amendment may be needed.
The Primary Site takes responsibility for all reporting to the CPI on behalf of the satellite sites. This includes ongoing reporting to HREC, annual reports and safety reports.